Devices and methods for heart valve repair

ABSTRACT

Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the-annulus. Anchors, which in some embodiments are super-clastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat with the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/6265,781, filed on Sep. 14, 2016, now issued as U.S. Pat No.10,092,402, which is a continuation of U.S. patent application Ser. No.14/156,347, filed on Jan. 15, 2014, now issued as U.S. Pat. No.9,468,528, which is a continuation of U.S. patent application Ser. No.12/132,161, filed on Jun. 3, 2008, now issued as U.S. Pat. No.8,641,727, which is a divisional of U.S. patent application Ser. No.10/741,130, filed on Dec. 19, 2003, now issued as U.S. Pat. No.8,287,555, which is a continuation-in-part of U.S. patent applicationSer. No. 10/656,797, filed on Sep. 4, 2003, now issued as U.S. Pat. No.7,753,922, the full disclosures of which are incorporated herein byreference. Patent application Ser. No. 10/741,130, now issued as U.S.Pat. No. 8,287,555, is also a continuation-in part of U.S. patentapplication Ser. No. 10/461,043, filed on Jun. 13, 2003, now issued asU.S. Pat. No. 6,986,775, which claims the benefit of U.S. ProvisionalApplication Nos. 60/388,935, filed on Jun. 13, 2002; 60/429,288, filedon Nov. 25, 2002; 60/445,890, filed on Feb. 6,2003; and 60/462,502,filed on Apr. 10, 2003, the full disclosures of which are allincorporated herein by reference.

U.S. patent application Ser. No. 10/741,130, filed on Dec. 19, 2003, nowissued as U.S. Pat. No. 8,287,555, also claims the benefit of U.S.Provisional Application Nos.: 60/459,735, filed on Apr. 1, 2003; and60/524,922, filed Nov. 24, 2003, the full disclosures of which arehereby incorporated by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates generally to medical devices and methods.More particularly, the invention relates to devices and methods forenhancing cardiovascular, valve repair, especially the repair of heartvalves such as me mitral and tricuspid valves.

In recent years, many advances have been made to reduce the invasivenessof cardiac surgery. In an attempt to avoid open, stopped-heartprocedures, which may be accompanied by high patient morbidity andmortality, many devices and methods have been developed for operating ona heart through smaller incisions, operating on a beating heart, andeven performing cardiac procedures via transvascular access. Differenttypes of cardiac procedures, such as cardiac ablation techniques fortreating atrial fibrillation, stenting procedures for atherosclerosis,and valve repair procedures for treating conditions such as mitral valveregurgitation have experienced significant technological advances. Inimplementing many minimally invasive cardiac-surgery techniques,especially beating-heart techniques, one of the most significantchallenges is positioning a treatment device (or multiple devices) in adesired location in or around the heart for performing the procedure.Another challenge, once a device is positioned, is to effectively deploya given treatment into or on the target cardiac tissue.

One type of cardiac surgery which may benefit from less invasivetechniques is heart valve repair. Traditional treatment of heart valvestenosis or regurgitation, such as mitral or tricuspid regurgitation,typically involves an open-heart surreal procedure to replace or repairthe valve. Valve repair procedures typically involve annuloplasty, a setof techniques designed to restore the valve annulus shape and strengthenthe annulus. Conventional annuloplasty surgery generally requires alarge incision into the thorax of the patient (a thoracotomy), andsometimes a median sternotomy (cutting through the middle of thesternum). These open heart, open chest procedures routinely involveplacing the patient on a cardiopulmonary bypass machine for sustainedperiods so that the patient's heart and lungs can be artificiallystopped during the procedure. Finally, valve repair and replacementprocedures are typically technically challenging and require arelatively large incision through the wall of the heart to access thevalve.

Due to the highly invasive nature of open heart valve repair orreplacement, many patients, such as elderly patients, patients havingrecently other surgical procedures, patients with comorbid medicalconditions, children, late-stage heart failure patients, and the like,are often considered too high-risk to undergo heart valve surgery andare relegated to progressive deterioration and cardiac enlargement.Often, such patients have no feasible alternative treatments for theirheart valve conditions.

To obviate this situation, a number of devices and methods for repairingcardiac valves in a less invasive manner have been described. Somedevices provide for heart valve repair through minimally invasiveincisions or intravascularly, while others improve upon open heartsurgical procedures on beating hearts, stopped hearts or both. Asmentioned above, difficulties in performing minimally invasiveintracardiac surgery include positioning a minimally invasive treatmentdevice in a desired location for performing a procedure and effectivelydeploying a given treatment into or on the target cardiac tissue. Inheart valve repair procedures, for example, it is often essential for aphysician to secure one or more treatment devices to valve annulustissue. Annular tissue tends to be more fibrous than surroundingmuscular or valve leaflet tissue, thus providing a more suitablelocation for securing such treatment devices, such as anchors, to treata heart valve. Positioning an anchor deliver device in a desiredlocation adjacent the annular tissue may often be challenging,especially in an intravascular procedure when visualization of thelocation is limited.

Devices and methods that address these difficulties are described inU.S. Patent Application Ser. Nos. 60/445,890, 60/459,735, 60/462,502,60/524,622, Ser. Nos. 10/461,043, and 10/656,797, which were previouslyincorporated by reference. For example, these references describedevices and methods for exposing, stabilizing and/or performing aprocedure on a heart valve annulus, such as a mitral valve annulus. Manyof the devices and methods previously described by the inventors havebeen found to be highly effective, but improvements are still beingsought.

Therefore, it would be beneficial, to have improved devices and methodsfor performing a procedure on a heart valve annulus. Ideally, suchdevices could be conveniently positioned in a location for treatment ofa valve annulus. Also ideally, such devices and methods would providefor enhanced delivery of treatment devices to a valve annulus, forexample to enhance the securing of anchors to annular tissue. At leastsome of these objectives will be met by the present invention.

2. Description of the Background Art

Published U.S. Application 2002/0156526 describes a catheter-basedmethod for performing annuloplasty. Published U.S. Application2002/0042621 describes a heart valve annuloplasty system withconstrictable plication bands which are optionally attached to a linkagestrip. Published U.S. Application 2002/0087169 describes a remotecontrolled catheter system which can be used to deliver anchors and atether for performing an annuloplasty procedure. Other patentpublications of interest include WO01/26586; US2001/0005787;US2001/0014800; US2002/0013621; US2002/0029080; US2002/0035361;US2002/0042621; US2002/0095167; and US2003/0074012; U.S. patents ofinterest include U.S. Pat. Nos. 4,014,492; 4,042,979; 4,043,504;4,055,861; 4,700,250; 5,366,479; 5,450,860; 5,571,215; 5,674,279;5,709,695; 5,752,518; 5,848,969; 5,860,992; 5,904,651; 5,961,539;5,972,004; 6,165,183; 6,197,017; 6,250,308; 6,260,552; 6,283,993;6,269,819; 6,312,447; 6,332,893; and 6,524,338. Publications of interestinclude De Simone et al. (1993) Am. J. Cardiol. 73:721 -721, and Downinget al. (2001) Heart Surgery Forum, Abstract 7025. All of the above citedreferences are hereby incorporated by reference in the presentapplication.

BRIEF SUMMARY OF THE INVENTION

Devices and methods of the present invention are generally used tofacilitate transvascular, minimally invasive and other “less invasive”surgical procedures; by facilitating the delivery of treatment devicesat a treatment site. “Less invasive,” for the purposes of thisapplication, means any procedure that is less invasive than traditional,large -incision, open surgical procedures. Thus, a less invasiveprocedure may be an open surgical procedure involving one or morerelatively small incisions, a procedure performed via transvascularpercutaneous access, a transvascular procedure via cut-down, alaparoscopic or other endoscopic procedure, or the like. Generally, anyprocedure in winch a goal is to minimize or reduce invasiveness to thepatient may be considered less invasive. Furthermore, although the terms“less invasive” and “minimally invasive” may sometimes be usedinterchangeably in this application, neither these nor terms used todescribe a particular subset of surgical or other procedures should beinterpreted to limit the scope of the invention. Generally, devices andmethods of the invention may be used in performing or enhancing anysuitable procedure.

The present application typically describes devices and methods forperforming heart valve repair procedures, and more specifically heartvalve annuloplasty procedures such as mitral valve annuloplasty to treatmitral regurgitation. Devices and methods of the invention, however, maybe used in any suitable procedure, both cardiac and non-cardiac. Forexample, they may be used in procedures to repair any heart valve, torepair an atrial-septal defect, to access and possibly perform a valverepair or other procedure from (or through) the coronary sinus, to placeone or more pacemaker leads, to perform a cardiac ablation proceduresuch as ablating around pulmonary veins to treat atrial fibrillation,and/or the like. In other embodiments, the devices and methods may beused to enhance a laparoscopic or other endoscopic procedure on any partof the body, such as the bladder, stomach, gastroesophageal junction,vasculature, gall bladder, or the like. Therefore, although thefollowing description typically focuses on mitral valve and other heartvalve repair, such description should not be interpreted to limit thescope of the invention as defined by the claims.

That being said, the present invention generally provides devices andmethods for enhanced treatment of a cardiac valve annulus. Methodsgenerally involve contacting an anchor delivery device with a length ofa valve annulus, delivering a plurality of coupled anchors from theanchor delivery device to secure the anchors to the annulus, and drawingthe anchors together to circumferentially tighten the annulus. Devicesgenerally include an elongate catheter having a housing at or near thedistal end for releasably housing a plurality of coupled anchors.Devices may be positioned such that the housing abuts or is close tovalve annular tissue, such as at an intersection of the left ventricularwall and one or more mitral valve leaflets of the heart. Someembodiments include self securing anchors, which may change fromundeployed to deployed configurations. Anchors may be drawn together totighten the annulus by cinching a tether slidably coupled with theanchors and/or by a self-deforming member coupled with the anchors.

In many cases, methods of the present invention will be performed on abeating heart. Access to the beating heart may be accomplished by anyavailable technique, including intravascular, transthoracic, and thelike. Intravascular access to a heart valve may be achieved using anysuitable route or method. To perform a procedure on a mitral valve, forexample, in one embodiment a catheter may be advanced through a femoralartery, to the aorta, and into the left ventricle of the heart, tocontact a length of the mitral valve. Alternatively, access may begained through the venous system, to a central vein, into the rightatrium of the heart, and across the interatrial septum to the left sideof the heart to contact a length of the mitral valve. In either of thosetwo types of intravascular access; the catheter will often easily beadvanced, once it enters the left side of the heart, into a spacedefined by the left ventricular wall, one or more mitral valve leaflets,and chordae tendineae of the left ventricle. This space provides aconvenient conduit for further advancement of the catheter to a desiredlocation for performing mitral valve repair. In alternative embodiments,a catheter device may access die coronary sinus and a valve proceduremay be performed directly from the sinus. Furthermore, in addition tobeating heart access, methods of the present invention may be used forintravascular stopped heart access as well as stopped heart open chestprocedures. Any suitable intravascular or other access method iscontemplated within the scope of the invention.

In one aspect of the invention, a method of constricting a valve annulusin a heart involves contacting an anchor delivery device with a lengthof the valve annulus, delivering a plurality of coupled anchors from theanchor delivery device to secure the anchors to the annulus, and drawingthe anchors together to circumferentially tighten the valve annulus. Insome embodiments, the anchors secure to the annulus by changing from anundeployed shape to a deployed shape upon their release from the anchordelivery device. Thus, the anchors may be called “self-securing” in thatthey secure to the tissue, at least in part, by changing from theundeployed shape to the deployed shape, and it is not required to crimp,drive or otherwise apply force to the anchors using the delivery device(although in some embodiments self-securing anchors may also be crimped,driven and/or the like.) In other embodiments, anchors non-self-securinganchors may be used, and such anchors may be secured to an annulus bydriving, crimping and/or the like. “Anchors,” which are described morefully below, are generally any devices that may be secured to a valveannulus.

In some embodiments, contacting the delivery device with the annuluscomprises deforming a flexible distal portion of the anchor deliverydevice lo conform the distal portion to the valve annulus. Deforming thedistal portion may be performed by any suitable method, such as applyingforce to a tensioning cord, expanding a shaped expandable member coupledWith the distal end, or the like. In some embodiments, for example,deforming the flexible distal portion comprises articulating the distalportion in at least two directions. For example, deforming the flexibledistal portion may involve applying tension to a first tensioning cordto cause a first bend in the distal portion. Optionally, deforming theflexible distal portion may further involve applying tension to a secondtensioning cord to cause a second bend in the distal portion. Forexample, the first bend may have approximately a C-shape to conform thedistal portion to the annulus, and the second bend may be upwardlydirected. In other embodiments, deforming the flexible distal portionmay involve introducing air, a fluid, of the like into a shape-memorydistal portion. Some embodiments may also include locking the shape ofthe flexible distal portion.

As mentioned previously, the contacting, delivering and drawing stepsmay be performed on any suitable heart valve such as a mitral,tricuspid, aortic or pulmonary valve, as well as on other heartstructures, such as a patent foramen ovale, or structures outside theheart, such as a gastroesophageal junction. For exemplary purposes only,devices and methods of the invention are often described below in thecontext of mitral valve repair for treatment of mitral regurgitation. Insuch mitral valve repair embodiments, as is also mentioned above, themethod may optionally include advancing the flexible distal portion ofan anchor delivery device within a space defined by the left ventricularwall, at least one mitral valve leaflet and at least one chordaetendineae of the left ventricle. It has been found that an elongate,flexible catheter may be conveniently passed under a mitral valveleaflet, into this subvalvular space, and advanced circumferentiallyaround part or all of the circumference of the mitral valve. Tissue ofthe mitral valve annulus is typically located at a corner of this spacedefined by the intersection of the left ventricular wall and theinferior side of the mitral valve leaflet(s). Thus, passing a flexibledistal portion of an elongate catheter into the subvalvular space mayposition the flexible distal portion in a desirable location fortreating the valve annulus. For example, delivering anchors to contactand secure themselves to annular tissue is favorable to delivering theanchors to contact heart muscle or valve leaflet tissue, since annulartissue is more fibrous arid thus more suitable for holding anchors,clips and the like. To further enhance contact of an anchor deliverydevice with a valve annulus the method may optionally include expandingan expandable member coupled with the delivery device within thetreatment space to urge, wedge or press the delivery device further intothe intersection of the left ventricular wall and the mitral valveleaflet(s).

In alternative embodiments, the anchor delivery device may be contactedwith the valve annulus from within the left atrium of the heart. In someembodiments, a portion of the device may be contacted with the valveannulus from both the left atrium and the left ventricle. In suchembodiments, the method may involve contacting the valve annulus with ananchor delivery device disposed in the left ventricle, contacting thevalve annulus with a stabilizing member disposed in the left atrium, anddelivering anchors from the anchor delivery device to contact and secureto the annulus. Stabilization devices and the combination ofstabilization devices and anchor delivery devices ate described morefully in U.S. patent application Ser. Nos. 10/461,043 and 10/656,797,which were previously incorporated by reference.

In some embodiments, delivering the plurality of tethered anchors mayinvolve simply releasing the anchors from the delivery device.Alternatively, the anchors may De driven or otherwise forced from thedelivery device. In some embodiments, delivering the plurality oftethered anchors comprises applying force to each of the anchors with ananchor contacting member. The anchor contacting member may be anysuitable device disposed within the delivery device for contacting andapplying force to the anchors and, thus, to force the anchors out of oneor more openings in the delivery device. For example, a ball, plunger orother similar device coupled with a tether or “pull cord” may bedisposed in a delivery device distal to a distal-most anchor. The ballmay then be pulled or retracted proximally, relative to the deliverydevice, to sequentially contact the anchors and force each anchor out ofthe device. In an alternative embodiment, delivering the plurality ofanchors may involve retracting at least one anchor retaining mandrel ofthe-anchor delivery device to release the anchors. In some embodiments,for example, two mandrels are retracted, each mandrel positioned toretain an arm of each anchor. In another embodiment, one mandrel may beused, or any other suitable number of mandrels. In some embodiments, forexample, each anchor has an opened arcuate undeployed shape and assumesa closed shape with overlapping ends after release from constraint. Insuch embodiments, two mandrels may be used, each mandrel retaining an“arm” of the opened arcuate shape.

Anchors, which may be any type of fastener devices, may have anysuitable deployed and undeployed shapes and sizes, may be made from anysuitable material(s), and the like. In some embodiments, the anchors aregenerally straight in their undeployed shape, so as to fit within arelatively narrow delivery catheter. Each anchor may have two sharpenedtips and a small loop or similar shape between the tips, through which atether may be passed. Upon deployment, the two sharpened tips may curvein opposite directions, to “bite” into and secure themselves to tissue.In various embodiments, the tips may continue to curve to any suitabledegree—i.e., they may form semicircles, complete circles, overlappinghelices, partial or complete ovoid shapes, or the like. In otherembodiments, the undeployed shape may be approximately a C-shape orsemicircle having two sharpened ends, and the deployed shape may be aclosed circle in which the two ends overlap, wherein upon release fromthe delivery device the anchors secure to the annulus by penetrating theannulus with the ends and subsequently assuming the closed circle shape.These and other anchor embodiments typically have sharpened ends or tipsto allow the anchors to secure to tissue. For example, the ends of anopen C or semicircle bite into annular tissue, continue to close, andthen overlap, so that the anchor is securely fastened to the tissue andno cuds protrude. In some embodiments, such anchors will be flush withthe surface of the tissue when deployed, so that no space exists betweena portion of the anchor and the tissue.

In various embodiments, the tethered anchors may be released from thedelivery device simultaneously or sequentially. For example, if aretractable anchor contacting member is used, it may contact one anchorat a time to force the anchors out sequentially. In other embodimentswhere one or more anchor retaining mandrels are used, the mandrel(s) maybe retracted quickly enough in some embodiments so that the anchors areall released from the housing simultaneously. In another embodiment, themandrel may be retracted more slowly, such that one anchor or severalanchors at a time may be released and then subsequent anchors maysubsequently be released. Some embodiments may further involve drivingthe anchors out of the delivery device using at least one expandableballoon member disposed within the delivery device. In alternativeembodiments, a staple- or clip-driving device may be used. Althoughcoupled anchors are typically used alone to tighten a valve annulus, insome embodiments coupled anchors may be used to secure a prosthesis to aheart valve annulus, such as an artificial valve, a Dacron cuff, anytype of valve repair ring, or the like.

Drawing the anchors together to tighten the valve annulus may include,for example, cinching a tether extending through an eyelet on each ofthe plurality of anchors. Alternatively, a tether may be disposedbetween each of the plurality of anchors and the annulus, without theanchors having eyelets. In some embodiments, a self-deforming couplingmember extending between the anchors may be used instead of or inaddition to a tether to constrict the annulus. For example, aself-deforming “backbone” made of super-elastic or shape-memory materialsuch as Nitinol may be coupled with the anchors, such that when thetethered anchors and the backbone are released to allow the anchors tosecure to the annular tissue, the backbone constricts to bring theanchors closer together and thus constrict the annulus. In oneembodiment, such a backbone is shaped generally as a straight or curvedline before deployment and assumes a configuration having multiple bendsafter deployment. The multiple bends reduce the overall length of thebackbone, thus acting to cinch the anchors to constrict the annulus. Insome embodiments, a tether and a self-deforming coupling member may beused together to tighten the valve annulus, and the tether and thecoupling member may optionality be coupled together.

In embodiments in which the anchors are slidably tethered, the methodtypically further includes cinching the tether, fixing the tether to atleast a terminal anchor pf the plurality of anchors, and cutting thetether to leave the cinched anchors in place, coupled with the valveannulus. Any or all of these steps may optionally be performed using a“termination device,” such as a termination catheter or sheath that isadvanced over the tether to a location near the terminal anchor. Theterminal anchor is typically the last anchor placed in the length of thevalve annulus, which may be the most proximal anchor relative to theoter anchors. A termination catheter, for example, may be used to applyoppositely-directed force While the tether is cinched. It may also housean adhesive device, such as a Nitinol knot positioned over the tether,for securing the tether to the terminal anchor. Once the tether iscinched and attached to the terminal anchor, a cutting device, such as aguillotine, coupled with the termination catheter may be used to cut thetether proximal to the terminal anchor to leave the cinched anchorsbehind, secured to the valve annulus. Alternatively, any other suitablemethods and devices may be used to provide cinching, attaching and/orcutting of a tether.

In some embodiments, a number of anchors may be applied to a firstlength of a valve annulus to tighten that length of the annulus, andthen a number of additional anchors may be applied to a second length ofthe annulus to tighten that length. Such a method may actually be moreconvenient, in some instances, than contacting a delivery device with alarger portion of the circumference of the annulus and applying andclinching all the anchors. For example, in one embodiment a deliverydevice is contacted with an anterior length of the valve annulus,anchors are released to contact and tighten the annulus, and then thedelivery device is contacted with a posterior length of the annulus andadditional anchors are released to contact and tighten the posteriorlength.

In some embodiments, the method may also include stabilizing the annuluswith the delivery device prior to releasing the anchors. Annulusstabilizing devices and methods are described in more detail, forexample, in U.S. patent application Ser. Nos. 10/461,043 and 10/656,797,which were previously incorporated by reference.

Methods may also optionally include visualizing the valve annulus.Visualization devices and methods are described more fully in U.S.Provisional patent application Ser. No. 60/500,773, filed on Sep. 3,2003, the full disclosure of which is hereby incorporated by reference.In some embodiments, for example, visualizing is performed using atleast one visualization device such as an ultrasound device, anangioscopic device, a transesophageal echocardiogram device and afluoroscopic device. In one embodiment, the ultrasound device comprisesa gel-containing cone for enhancing ultrasound visualization. In oneembodiment, visualizing comprises using a real-time Doppler ultrasounddevice to visualize a regurgitant flow across the heart valve during atleast the cinching step. In some embodiments, the method may further areduction in the regurgitant flow during the cinching step and selectingan amount of cinching based on the reduction in regurgitant flow. Insome embodiments, the visualization. device is coupled with the anchordelivery device. For example, the visualization device may comprise anangioscope having a viewing end within or adjacent to a lens, bubble orinflatable balloon which displaces blood to permit viewing in thebeating heart.

In another aspect of the invention, a method of constricting a valveannulus in a heart involves: contacting an anchor delivery device havinga cross-sectional diameter of about 1.67 mm or less with a length of thevalve annulus; delivering a plurality of coupled anchors from the anchordelivery device to secure the anchors to the annulus, each anchor havinga deployed shape with a radius of at least about 3 mm; and drawing theanchors together to circumferentially tighten the valve annulus. It hasbeen found that anchors may be disposed in and delivered from a deliverydevice in such away as to allow relatively large-radius anchors to bedelivered from a relatively small-diameter delivery device. Anywherefrom one anchor to 20 anchors may be delivered in some embodiments,although the invention is not limited to such numbers. In oneembodiment, for example, at least 10 anchors, each haying a deployedradius of about 3 mm or more, may be delivered from a delivery devicehaving a cross-sectional diameter of about 1.67 mm or less.

In another aspect, of the present invention, a device for applyingcoupled anchors to an annulus of a heart valve comprises: an elongateshaft having a proximal end and a distal end; a housing adjacent thedistal end; a plurality of coupled anchors disposed within the housing;at least one anchor contacting member for causing the anchors to bedelivered from the housing; and at least one actuator at or near theproximal end of the shaft for affecting the anchor contacting member tocause delivery of the anchors to the valve annulus.

In some embodiments, the elongate shaft comprises a flexible catheterwhich is advancable intravascularly to the heart. In a preferredembodiment, a flexible elongate shaft has a diameter of about 5 French(1.67 mm) or less and deploys anchors having a radius, when deployed, ofabout 3 mm or more. The housing itself may house any suitable number ofanchors. In one embodiment, for example, the housing holds between 1anchor and 20 anchors, and more preferably about 3-10 anchors, and inone embodiment 10 anchors. Also in some embodiments, the housing issufficiently flexible to allow the housing to conform to the annulus.For example, the housing may conform to the annulus at an intersectionof a left ventricular wall and one or more mitral valve leaflets of theheart. The housing may thus be positioned or advanced through thesubvalvular space as discussed above. In some embodiments, the housingis coupled with an actuator for deforming the housing to conform it tothe annulus. The housing may have any suitable configuration, but insome embodiments it has a cross section with a shape that is roughlysemi-circular, circular, oval, part of an oval, a partial or completeellipse, or the like. For example, a housing with an elliptical shapemay sometimes be used to help ensure that an anchor delivering surfaceof the housing comes into contact with the annular tissue. In variousembodiments, the housing may have one or multiple openings for allowingegress of the anchors. In one embodiment, for example, the housing hasmultiple openings, each opening suitable for egress of one anchor.

In some embodiments, the housing includes a shape-changing portion,typically a distal portion. Such embodiments may further include a firsttensioning cord coupled with the shape-changing portion for applyingtension to the shape-changing portion to cause it to bend in at least afirst direction. Optionally, a second tensioning cord may be coupledwith the shape-changing portion for applying tension to theshape-changing portion to cause it to bend in at least a seconddirection. The first direction, for example, may be approximately aC-shape for conforming to the annulus and the second direction comprisesan upward or proximal direction for applying force to the annulus. Insome embodiments, the shape-changing portion includes multiple notchesalong at least one side to control bending into a curve which conformsto the shape of the annulus. Alternatively, the shapes-changing portionmay comprise multiple stacked segments coupled with at least the firsttensioning member to control bending into the shape of the annulus. Inother embodiments, the shape-changing portion comprises a shape-memorymaterial configured to conform to the shape of the annulus. In someembodiments, the shape-changing portion further comprises at least onelumen for introducing a fluid to cause the shape-memory material toconform to the shape of the annulus. The distal portion of the housingmay alternatively be coupled with a shaped expandable balloon fordeforming the distal portion. In some embodiments, the housing may becoupled with an expandable member such that when the expandable memberexpands, it helps wedge, drive or press the housing against valveannulus tissue. For example, such an expandable member may help to wedgea housing into the corner formed by a ventricular wall and a valveleaflet.

As explained above, anchors of the device may have any suitable shape,size and properties and may be made of any suitable materials. Anchorsmay be self-deforming in some embodiments, thus having an undeployedshape when constrained in the housing, of the delivery device andassuming a deployed shape after release from the housing. In oneembodiment, each of the plurality of coupled anchors has a generallystraight configuration, with two sharpened tips and a loop between thetwo. Upon deployment, such an anchor may curve, with each tip curving inan opposite direction to bite into tissue. The loop, in turn, may act asan eye for a tether. In another embodiment, each anchor may have aC-shaped or semicircular undeployed shape and an overlapping circle orkey ring deployed shape. In such an embodiment, the open ends of the Care typically sharpened, to enable the anchor to enter tissue of a valveannulus. As the C-shaped anchor contacts and enters the tissue, it alsocloses, and the ends overlap to form a circle or key-ring-shapeddeployed anchor. Such an anchor may be applied such that it rests flushwith the surface of the annular tissue without protruding sharp ends orother parts. The anchors may be made of Nitinol, shape-memory stainlesssteel, or any other super-elastic or shape-memory material.Alternatively, the anchors may be spring loaded or otherwise housedwithin the housing so as to change from an undeployed to a deployedshape upon release from the housing.

In some embodiments, the anchors are slidably coupled with a tether. Insuch embodiments, each of the plurality of anchors may include at leastone eyelet, with the tether slidably passing through the eyelet of eachanchor. Alternatively, the tether may extend along the anchors to bepositioned between the anchors and annular tissue upon deployment. Inother embodiments, the anchors may be coupled by a self-deformingcoupling member fixedly coupled with each anchor. For example, thecoupling member (or “backbone”) may comprise a Nitinol member having anundeployed shape approximating a straight line and a deployed shape of atine having multiple bends. Upon changing from the undeployed shaped tothe deployed shape, the coupling member may cinch the anchors tocircumferentially tighten the valve annulus. Some embodiments mayinclude both a tether and a self-deforming coupling member, with bothbeing available to provide cinching of a valve annulus.

In some embodiments, the at least one anchor contacting member comprisesat least one retractable force applying device which, when retractedproximally relative to the housing, sequentially contacts the anchors toapply force to the anchors such that they exit the housing via at leastone opening in the housing. Such a force applying device, for example,may comprise a ball, plate, anchor, hook, plunger or the like, coupledwith a cord, wire, tether or the like. When the tether is pulledproximally, the ball contacts the distal-most anchor in the deliverydevice and forces it out an opening in the device. When retractedfurther, the ball then contacts the next anchor, forcing it out, and soon. In alternative embodiments, the at least one anchor contactingmember comprises at least one movable retaining member. For example,such a movable retaining member may comprise one or more anchorretaining mandrels, slidably disposed in the housing so that retractingthe mandrel(s) releases one or more of the anchors. Sometimes, forexample, two mandrels are positioned in the housing to retain two armsof each anchor, for example when the undeployed shape of each anchor isapproximately a C-shape or semicircle. The mandrel (or mandrels) maytypically be retracted to release anchors one at a time, in groups, orall at once.

In some embodiments, the at least one actuator includes means forcinching the coupled anchors to reduce the circumference of the valveannulus. Such an actuator may comprise, for example, a trigger, ahandle, a plunger, a squeeze-activated device, a syringe-grip device, afoot-operated device, or the like. Some embodiments of the device alsoinclude at least one expandable member disposed within the housing forpushing the anchors out of the housing.

In yet another aspect of the invention, a device for, applying multipletethered anchors to an annulus of a heart valve comprises; a flexibleelongate catheter having a distal portion for delivering the tetheredanchors, the distal portion having a cross-sectional diameter of about1.67 mm or less; a plurality of tethered anchors disposed within thedistal portion, each anchor having a radius of at least about 3 mm whendeployed from the housing; and at least one anchor delivery membercoupled with the catheter for causing the anchors to be delivered fromthe catheter.

In another aspect of the invention, a self-securing anchor for attachingto annular tissue of a heart valve comprises a super-elastic orshape-memory material having a relatively elongate undeployed shapeallowing the anchor to be disposed within a delivery catheter havingacross-sectional diameter of 1.67 mm or less, and assuming a deployedshape with a radius of at least 3 mm upon its release from the deliverydevice. Generally, such an anchor may have two sharpened tips of theanchor curve in opposite directions when the anchor is released from thedelivery device. Optionally, the anchor may include an eyelet disposedbetween the two sharpened tips.

In still another aspect of the present invention, a self-securing anchorfor attaching to annular tissue of a heart valve comprises ashape-memory material having an opened arcuate undeployed shape andassuming a closed shape with overlapping ends after release fromconstraint. The undeployed and deployed shapes may be any suitableshapes. In one embodiment, for example, the undeployed shape isapproximately a C-shape or semicircle having two sharpened ends, and thedeployed shape is a closed circle in which the two ends overlap. In someembodiments, the anchor is configured to lie flush with the annulartissue when secured to the tissue. Any super-elastic or shape-memorymaterial may be used to form the anchor, such as Nitinol or any othersuitable material.

These and other embodiments are described more fully below withreference to the drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a heart with a flexible anchordelivery device being positioned for treatment of a mitral valveannulus, according to one embodiment of the present invention;

FIGS. 2A and 2B are cross-sectional views of a portion of a heart,schematically showing positioning of a flexible device for treatment ofa mitral valve annulus, according to one embodiment of the presentinvention;

FIGS. 2C and 2D are cross-sectional views of a portion of a heart,showing positioning of a flexible anchor delivery device for treatmentof mitral valve annulus, according to one embodiment of the presentinvention;

FIG. 3 is a perspective view of a distal portion of an anchor deliverydevice, according to one embodiment of the invention;

FIG. 4 is a perspective view of a segment of a distal portion of ananchor delivery device, with anchors in an undeployed shape andposition;

FIG. 5 is a different perspective view of the segment of the deviceshown in FIG. 4;

FIG. 6 is a perspective view of a segment of a distal portion of ananchor delivery device, with anchors a deployed shape and position;

FIGS. 7A-7E are cross-sectional views of an anchor delivery device,illustrating a method for delivering anchors to valve annulus tissue,according to one embodiment of the invention;

FIGS. 8A and 8B are top-views of a plurality of anchors coupled to aself-deforming coupling member or “backbone,” with the backbone shown inah undeployed shape and a deployed shape;

FIGS. 9A-9C are various perspective views of a distal portion of aflexible anchor delivery device according to one embodiment of thepresent invention; and

FIGS. 10A-10F demonstrate a method for applying anchors to a valveannulus and cinching the anchors to tighten the annulus, using an anchordelivery device according to an embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Devices and methods of the present invention are generally used tofacilitate transvascular, minimally invasive and other “less invasive”surgical procedures, by facilitating the delivery of treatment devicesat a treatment site. Although the following description focuses on viseof devices and methods of the invention for mitral valve repair, thedevices and methods may be used in any suitable procedure, both cardiacand non-cardiac. When used for treatment of a cardiac valve annulus, theinventive methods generally involve contacting an anchor delivery devicewith a length of the valve annulus, delivering a plurality of coupledanchors from the anchor delivery device, and drawing the anchorstogether to tighten the annulus. Devices generally include an elongatecatheter having a housing at or near the distal end for releasablyhousing a plurality of coupled anchors. Devices may be positioned suchthat the housing abuts or is close to valve annular tissue, such as in alocation within the loft ventricle defined by the left ventricular wall,a mitral valve leaflet and chordae tendineae. Self-securing anchorshaving any of a number of different configurations may be used in someembodiments.

In many cases, methods of the present invention will be performed on abeating heart. Access to the beating heart may be accomplished by anyavailable technique, including intravascular, transthoracic, and thelike. In addition to beating heart access, the methods of the presentinvention may be used for intravascular stopped heart access as well asstopped heart open chest procedures.

Referring now to FIG. 1, a heart H is shown in cross section, with anelongate anchor delivery device 100 introduced within the heart H.Generally, delivery device 100 comprises an elongate body with a distalportion 102 configured to deliver anchors to a heart valve annulus. (InFIGS. 1, 2A and 2B, distal portion 102 is shown diagrammatically withoutanchors or anchor-delivery mechanism to enhance clarity of the figures.)In some embodiments, the elongate body comprises a rigid shaft, while inother embodiments it comprises a flexible catheter, so that distalportion 102 may be positioned in the heart H and under one or more valveleaflets to engage a valve annulus via a transvascular approach.Transvascular access may be gained, for example, through the internaljugular vein (not shown) to the superior vena cava SVC to the rightatrium RA, across the interatrial spectrum to the left atrium LA, andthen under one or more mitral Valve leaflets MVL to a position withinthe left ventricle (LV) under the valve annulus (not shown).Alternatively, access to the heart may be achieved via the femoral veinand the inferior vena cava. In other embodiments, access may be gainedvia the coronary sinus (not shown) and through the atrial wall into theleft atrium. In still other embodiments, access may be achieved via afemoral artery and the aorta, into the left ventricle, and under themitral valve. Any other suitable access route is also contemplatedwithin the scope of the present invention.

In other embodiments, access to the heart H may be transthoracic, withdelivery device 100 being introduced into the heart via an incision orport on the heart wall. Even open heart surreal procedures may benefitfrom methods and devices of the invention. Furthermore, some embodimentsmay be used to enhance procedures on the tricuspid valve annulus,adjacent the tricuspid valve leaflets TVL, or any other cardiac orvascular valve. Therefore, although the following description typicallyfocuses on minimally invasive or less invasive mitral valve repair fortreating mitral regurgitation, the invention is in ho way limited tothat use.

With reference now to FIGS. 2A and 2B, a method for positioning deliverydevice 100 for treating a mitral valve annulus VA is depicteddiagrammaUcally in a cross-sectional view. First, as in FIG. 2A, distalportion 102 is positioned in a desired location under a mitral valveleaflet L and adjacent a ventricular wall VW. (Again, distal portion 102is shown without anchors or anchor-delivery mechanism for demonstrativepurposes.) The valve annulus VA generally comprises an area of heartwall tissue at the junction of the ventricular wall VW and the atrialwall AW that is relatively fibrous and, thus, significantly strongerthat leaflet tissue and other heart wall tissue.

Distal portion 102 maybe advanced into position under the valve annulusby any suitable technique, some of which are described below in furtherdetail. Generally, distal portion 102 may be used to deliver anchors tothe valve annulus, to stabilize and/or expose the annulus, or both. Inone embodiment, using a delivery device having a flexible elongate bodyas shown in FIG. 1, a flexible distal portion 102 may be passed from theright atrium RA through the interatrial septum in the area of theforamen ovale (not shown—behind the aorta A), into the left atrium LAand thus the left ventricle LV. Alternatively, flexible distal portion102 maybe advanced through the aorta A and into the left ventricle LV,for example using access through a femoral artery. Oftentimes, distalportion 102 will then naturally travel, upon further advancement, underthe posterior valve leaflet L into a space defined above a subvalvularspace 104 roughly defined for the purposes of this application as aspace bordered by the inner surface of the led ventricular wall VW, theinferior surface of mitral valve leaflets L, and cordae tendineae CTconnected to the ventricular wall VW and the leaflet L. It has beenfound that a flexible anchor delivery catheter, such as the deliverydevices of the present invention, when passed under the mitral valve viaan intravascular approach, often enters subvalvular space 104 relativelyeasily and may be advanced along space 104 either partially orcompletely around the circumference of the valve. Once in space 104,distal portion 102 may be conveniently positioned at the intersection ofthe valve leaflets) and the ventricular wall VW, which intersection isimmediately adjacent or very near to the valve annulus VA, as shown inFIG. 2A. These are but examples of possible access routes of an anchordelivery device to a valve annulus, and any other access routes may beused.

In some embodiments, distal portion 102 includes a shape-changingportion which enables distal portion 102 to conform to the shape of thevalve annulus VA. The catheter may be introduced through the vasculaturewith the shape-changing distal portion in a generally straight, flexibleconfiguration. Once it is in place beneath the leaflet at theintersection between the leaflet and the interior ventricular wall, theshape of distal portion 102 is changed to conform to the annulus andusually the shape is “locked” to provide sufficient stiffness orrigidity to permit the application of force from distal portion 102 tothe annulus. Shaping and optionally locking distal portion 102 maybeaccomplished in any of a number of ways. For example, in someembodiments, a shape-changing portion may be sectioned, notched, slottedor segmented and one of more tensioning cords, wires or other tensioningdevices coupled with the shape-changing portion may be used to shape andrigidity distal portion 102. A segmented distal portion, for example,may include multiple segments coupled with two tensioning cords, eachcord providing a different direction of articulation to die distalportion. A first bend may be created by tensioning a first cord to givethe distal portion a C-shape or similar shape to conform to the valveannulus, while a second bend may be created by tensioning a second cordto articulate the C-shaped member upwards against the annulus. Inanother embodiment, a shaped expandable member, such as a balloon, maybe coupled with distal portion 102 to provide for shapechanging/deforming. In various embodiments, any configurations andcombinations may be used to give distal portion 102 a desired shape.

In transthoracic and other embodiments, distal portion 102 may bepre-shaped, and the method may simply involve introducing distal portion102 under the valve leaflets. The pre-shaped distal portion 102 may berigid or formed from any suitable super-elastic or shape memorymaterial, such as nitinol, spring stainless steel, or the like.

In addition to delivering anchors to the valve annulus VA, deliverydevice 100 (and specifically distal portion 102) may be used tostabilize and/or expose the valve annulus VA. Such stabilization andexposure are described fully in U.S. patent application Ser. No.10/656,797, which was previously incorporated by reference. For example,once distal portion 102 is positioned under the annulus, force maybeapplied to distal portion 102 to stabilize the valve annulus VA, asshown in FIG. 2B. Such force may be directed in any suitable directionto expose, position and/or stabilize the annulus. For example, upwardand lateral force is shown in FIG. 2B by the solid-headed arrow drawnfrom the center of distal portion 102. In other cases, only upward, onlylateral, or any other suitable force(s) may be applied. With applicationof force to distal portion 102, the valve annulus VA is caused to riseor project outwardly, thus exposing tbc annulus for easier viewing andaccess. The applied force may also stabilize the valve annulus VA, alsofacilitating surgical procedures and visualization.

Some embodiments may include a stabilization component as well as ananchor delivery component. For example, some embodiments may include twoflexible members, one for contacting the atrial side of a valve annulusand me other for contacting the ventricular side. In some embodiments,such flexible members may be used to “clamp” the annulus between them.One of such members may be an anchor delivery member and the other maybe a stabilization member, for example. Any combination andconfiguration of stabilization and/or anchor delivery members iscontemplated.

Referring now to FIGS. 2C and 2D, an anchor delivery device 108 is showndelivering an anchor 110 to a valve annulus VA. Of course, these areagain representational figures and are not drawn to scale. Anchor 110 isshown first housed within delivery device 108 (FIG. 2C) and thendelivered to the annulus VA (FIG. 2D). As is shown, in one embodimentanchors 110 may have a relatively straight configuration when housed indelivery device 108, perhaps with two sharpened tips and a loop inbetween the tips. Upon deployment from delivery device 108, the tips ofanchor 110 may curve in opposite directions to form two semi-circles,circles, ovals, overlapping helices or the like. This is but one exampleof a type of self-securing anchor which may be delivered to a valveannulus. Typically, multiple coupled anchors 110 are delivered, and theanchors 110 are drawn together to tighten the valve annulus. Methods foranchor delivery and for drawing anchors together are described furtherbelow.

Although delivery device 108 is shown having a circular cross-sectionalshape in FIGS. 2C and 2D, it may alternatively have any other suitableshape. In one embodiment, for example, it may be advantageous to providea delivery device having an ovoid or elliptical cross-sectional shape.Such a shape may help ensure that the device is aligned, when positionedbetween in a corner formed by a ventricular wall and a valve leaflet,such that one or more openings in the delivery device is oriented todeliver the anchors into valve annulus tissue. To further enhancecontacting of the valve annulus and/or orientation of the deliverydevice, some embodiments may further include an expandable member,coupled with the delivery device, which expands to urge or press orwedge the delivery device into the corner formed by the ventricle walland the leaflet to contact the valve annulus. Such enhancements aredescribed further below.

With reference now to FIG. 3, one embodiment of a portion of an anchordelivery device 200 suitably includes an elongate shaft 204 having adistal portion 202 configured to deliver a plurality of anchors 210,coupled with a tether 212, to tissue of a valve annulus. Tetheredanchors 210 are housed within a housing 206 of distal portion 202, alongwith one or more anchor retaining mandrels 214 and an expandable member208. Many variations may be made to one or more of these features, andvarious parts maybe added or eliminated, without departing from thescope of the invention. Some of these variations are described furtherbelow, but no specific embodiment(s) should be construed to limit thescope of the invention as defined by the appended claims.

Housing 206 may be flexible or rigid in various embodiments. In someembodiments, for example, flexible housing 206 may be comprised ofmultiple segments configured such that housing 206 is deformable bytensioning a tensioning cord coupled to the segments. In someembodiments, housing 206 is formed from an elastic material having ageometry selected to engage and optionally shape or constrict the valvestimulus. For example, the rings may be formed from super-elasticmaterial, shape memory alloy such us Nitinol, spring stainless steel, orthe like. In other instances, housing 206 could be formed from aninflatable or other structure can be selectively rigidified in situ,such as a gooseneck or lockable element shaft, any of the rigidifyingstructures described above, or any other rigidifying structure.

“Anchors,” for the purposes of this application, is defined to mean anyfasteners. Thus, anchors 210 may comprise C-shaped or semicircularhooks, curved hooks of other shapes, straight hooks, barbed hooks, clipsof any kind, T-tags, or any other suitable fastener(s). In oneembodiment, as described above, anchors may comprise two tips that curvein opposite directions upon deployment; forming two intersectingsemi-circles, circles, ovals, helices or the like. In some embodiments,anchors 210 are self-deforming. By “self-deforming” it is meant thatanchors 210 change from a first undeployed shape to a second deployedshape upon release of anchors 210 from restraint in housing 206. Suchself-deforming anchors 210 may change shape as they are released fromhousing 206 and enter valve annulus tissue, to secure themselves to thetissue. Thus, a crimping device or other similar mechanism is notrequired on distal end 202 to apply force to anchors 210 to attach themto annular tissue. Self-deforming anchors 210 may be made of anysuitable material, such as a super-elastic, or shape-memory materiallike Nitinol or spring stainless steel. In other embodiments, anchors210 may be made of a non-shape-memory material and made be loaded intohousing 206 in such a way that they change shape upon release.Alternatively, anchors 210 that are not self-deforming may be used, andsuch anchors may be secured to tissue via crimping, firing or the like.Even self-securing anchors may be crimped in some embodiments, toprovide enhanced attachment to tissue. Delivery of anchors maybeaccomplished by any suitable device and technique, such as by simplyreleasing the anchors by hydraulic balloon delivery as discussed furtherbelow. Any number, size and shape of anchors 210 may be included inhousing 206.

In one embodiment, anchors 210 are generally C-shaped or semicircular intheir undeployed form, with the ends of the C being sharpened topenetrate tissue. Midway along the C-shaped anchor 210, an eyelet may beformed for allowing slidable passage of tether 212. To maintain anchors210 in their C-shaped, undeployed state, anchors 210 may be retainedwithin housing 206 by two mandrels 214, one mandrel 214 retaining eachof the two arms of the C-shape of each anchor 210. Mandrels 214 may beretractable within elongate catheter body 204 to release anchors 210 andallow them to change from their undeployed C-shape to a deployed shape.The deployed shape, for example, may approximate a complete circle or acircle with overlapping ends, the latter appearing similar to a keyring. Such anchors are described further below, but generally may beadvantageous in their ability to secure themselves to annular tissue bychanging from their undeployed to their deployed shape. In someembodiments, anchors 210 are also configured to lie flush with a tissuesurface after being deployed. By “flush” it is meant that no significantamount of an anchor protrudes from the surface, although some smallportion may protrude.

Tether 212 may be one long piece of material or two or more pieces andmay comprise any suitable material, such as suture, suture-likematerial, a Dacron strip or the like. Retaining mandrels 214 may alsohave any suitable configuration and be made of any suitable material,such as stainless steel, titanium, Nitinol, or the like. Variousembodiments may have one mandrel, two mandrels, or more than twomandrels.

In some embodiments, anchors 210 may be released from mandrels 214 tocontact and secure themselves to annular tissue without any furtherforce applied by delivery device 200. Some embodiments, however, mayalso include one or more expandable members 208, which may be expandedto help drive anchors 210 into tissue. Expandable member(s) 208 may haveany suitable size and configuration and may be made of any suitablematerial(s). Hydraulic systems such as expandable members are known inthe art, and any known or as yet undiscovered expandable member may beincluded in housing 206 as part of the present invention.

Referring now to FIGS. 4 and 5, a segment of a distal portion 302 of ananchor delivery device suitably includes a housing 306, multipletensioning cords 320 for applying tension to housing 306 to change itsshape, two anchor retaining mandrels 314 slidably disposed in housing306, multiple anchors 310 slidably coupled with a tether 312, and anexpandable member 308 disposed between anchors 310 and housing 306. Ascan be seen in FIGS. 4 and 5, housing 306 may include multiple segmentsto allow the overall shape of housing 306 to be changed by applyingtension to tensioning cords 320. As also is evident from the drawings,“C-shaped” anchors 310 may actually have an almost straightconfiguration when retained by mandrels 314 in housing 306. Thus, forthe purposes of this application, “C-shaped” or “semicircular” refers toa very broad range of shapes including a portion of a circle, a slightlycurved line, a slightly curved line with an eyelet at one point alongthe line, and the like.

With reference now to FIG 6, the same segment of distal portion 302 isshown, but mandrels 314 have been withdrawn from two mandrel apertures322, to release anchors 310 from housing 306. Additionally, expandablemember 308 has been expanded to drive anchors out of housing 306.Anchors 310, having been released from mandrels 314, have begun tochange from their undeployed, retained shape to their deployed, releasedshape.

Referring now to FIGS. 7A-7E, a cross-section of a distal portion 402 ofan anchor delivery device is shown in various stages of delivering ananchor to tissue of a valve annulus VA. In FIG. 7A, distal portion 402is positioned against the valve annulus, an anchor 410 is retained bytwo mandrels 414, a tether 412 is slidably disposed through an eyelet onanchor 410, and an expandable member 408 is coupled with housing 406 ina position to drive anchor 410 out of housing 406. When retained bymandrels 414, anchor 410 is in its undeployed shape. As discussed above,mandrels 414 may be slidably retracted, as designated by solid-tippedarrows in FIG. 7A, to release anchor 410. In various embodiments,anchors 410 may be released one at a time, such as by retractingmandrels 414 slowly, may be released in groups, or may all be releasedsimultaneously, such as by rapid retraction of mandrels 414.

In FIG. 7B, anchor 410 has begun to change from its undeployed shape toits deployed shape (as demonstrated by the hollow-tipped arrows) and hasalso begun to penetrate the annular tissue VA. Empty mandrel apertures422 demonstrate that mandrels 414 have been retracted at least farenough to release anchor 410. In FIG. 7B, expandable member 408 has beenexpanded to drive anchor 410 partially put of housing 406 and furtherinto the valve annulus VA. Anchor 430 also continues to move from itsundeployed towards its deployed shape, as shown by the hollow-tippedarrows. In FIG. 7D, anchor 410 has reached its deployed shape, which isroughly a completed circle with overlapping ends or a “key ring” shape.In FIG. 7E, delivery device 402 has been removed, leaving a tetheredanchor in place in the valve annulus. Of course, there will typically bea plurality of tethered anchors secured to the annular tissue. Tether412 may then be cinched to apply force to anchors 410 und cinch andtighten the valve annulus.

With reference now to FIGS. 8A and 8B, a diagrammatic representation ofanother embodiment of coupled anchors is shown. Here, anchors 510 arecoupled to a self-deforming or deformable coupling member or backbone505. Backbone 505 may be fabricated, for example, from Nitinol, springstainless steel, or the like, and may have any suitable size orconfiguration. In one embodiment, as in FIG. 8A, backbone 505 is shapedas a generally straight line when held in an undeployed state, such aswhen restrained within a housing of art anchor deliver device. Whenreleased from the delivery device, backbone 505 may change to a deployedshape having multiple bends, as shown in FIG. 8B. By bending, backbone505 shortens the longitudinal distance between anchors, as demonstratedby the solid-tipped arrows in FIG. 8B. This shortening process may actto cinch a valve annulus into which anchors 510 have be secured. Thus,anchors 510 coupled to backbone 505 may be housed to cinch a valveannulus without using a tether or applying tethering force.Alternatively, a tether may also be coupled with anchors 510 to furthercinch the annulus. In such an embodiment, backbone 505 will beat leastpartiality conformable or cinchable, such that when force is applied toanchors 510 and backbone 505 via a tether, backbone 505 bends further toallow further cinching of the annulus.

Referring now to FIGS. 9A-9C, in one embodiment a flexible distalportion of an anchor delivery device 520 suitably includes a housing 522coupled with an expandable member 524. Housing 522 may be configured tohouse multiple coupled anchors 526 and an anchor contacting member 530coupled with a pull cord 532. Housing 522 may also include multipleapertures 528 for allowing egress of anchors 526. For clarity, deliverydevice 520 is shown without a tether in FIGS. 9A and 9C, but FIG. 9Bshows that a tether 534 may extend through an eyelet, loop or otherportion of each anchor 526, and may exit each aperture 528 to allow forrelease of the plurality of anchors 526. The various features of thisembodiment are described former below.

In the embodiment shown in FIGS. 9A-9C, anchors 526 are relativelystraight and lie relatively in parallel with the long axis of deliverydevice 522. Anchor contacting member 530, which may comprise anysuitable device, such as a ball, plate, hook, knot, plunger, piston, orthe like, generally has an outer diameter that is nearly equal to orslightly less than the inner diameter of housing 522. Contacting member530 is disposed within the housing distal to a distal-most anchor 526,and is retracted relative to housing 522 by pulling pull cord 532. Whenretracted, anchor contacting member 530 contacts and applies force to adistal-most anchor 526 to release cause that anchor 526 to exit housing522 via one of-the apertures 528. Contacting member 530 is then pulledfarther proximally to contact and apply force to the next anchor 526 todeploy that anchor 526, and so on.

Retracting contacting member 530 to push anchors 526 out of apertures528 may help cause anchors 526 to avidly secure themselves to adjacenttissue. Using anchors 526 that are relatively straight/flat whenundeployed allows anchors 526 with relatively large deployed sizes to bedisposed in (and delivered from) a relatively small housing 522. In oneembodiment, for example, anchors 526 that deploy into a shapeapproximating two intersecting semi-circles, circles, ovals, helices, orthe like, and that have a radius of one of the semi-circles of about 3mm may be disposed within a housing 522 having a diameter of about 5French (1.67 mm) and more preferably 4 French (1.35 mm) or even smaller.Such anchors 526 may measure about 6 mm or more in their widestdimension. These are only examples, however, and other larger or smalleranchors 526 may be disposed within a larger or smaller housing 522.Furthermore, any convenient number of anchors 526 may be disposed withinhousing 522. In one embodiment, for example, housing 522 may hold about1-20 anchors 526, and more preferably about 3-10 anchors 526. Otherembodiments may hold more anchors 526.

Anchor contacting member 530 and pull cord 532 may have any suitableconfiguration and may be manufactured from any material or combinationof materials. In alternative embodiments, contacting member 530 may bepushed by a pusher member to contact and deploy anchors 526.Alternatively, any of the anchor deployment devices and methodspreviously described may be used.

Tether 534, as shown in FIG. 9B, may comprise any of the tethers 534 ortether -like devices already described above, or any other suitabledevice. Tether 534 is generally attached to a distal-most anchor 526 atan attachment point 536. The attachment itself may be achieved via aknot, weld, adhesive, or by any other suitable attachment means. Tether234 then extends through an eyelet, loop or other similar configurationon each on each of the anchors 526 so as to be slidably coupled with theanchors 526. In the embodiment shown, tether 534 exits each aperture528, then enters the next-most-proximal aperture, passes slidablythrough a loop on an anchor 526, and exits the same aperture 528. Byentering and exiting each aperture 528, tether 534 allows the pluralityof anchors 526 to be deployed into tissue and cinched. Otherconfigurations of housing 522, anchors 526 and tether 534 mayalternatively be used. For example, housing 522 may include alongitudinal slit through which tether 534 may pass, thus allowingtether 534 to reside wholly within housing before deployment.

Expandable member 524 is an optional feature of anchor delivery device520, and thus maybe included in some embodiments and hot in others. Inother words, a distal portion of anchor delivery device 520 may includehousing, contents of housing, and other features either with or/withoutan attached expandable member. Expandable member 524 may comprise anysuitable expandable member currently known or discovered in the future,and any method and substance(s) may be used to expand expandable member524. Typically, expandable member 524 will be coupled with a surface ofhousing 522, will have a larger radius than housing 522, and will beconfigured such that when it is expanded as housing 522 nears orcontacts the valve annulus, expandable member 524 will push or presshousing 522 into enhanced contact with me annulus. For example,expandable member 524 may be configured to expand within a space nearthe corner formed by a left ventricular wall and a mitral valve leaflet.

With reference now to FIGS. 10A-10F, a method is shown for applying aplurality of tethered anchors 526 to a valve annulus VA in a heart. Asshown in FIG. 10A, an anchor delivery device 520 is first contacted withthe valve annulus VA such that openings 528 are oriented to deployanchors 526 into the annulus. Such orientation may be achieved by anysuitable technique. In one embodiment, for example, a housing 522 havingan elliptical cross-sectional shape may be used to orient openings 528.As just described, contact between housing 522 and the valve annulus VAmay be enhanced by expanding expandable member 524 to wedgehousing-within a corner adjacent the annulus.

Generally, delivery device 520 may be advanced into any suitablelocation for treating any valvs by any suitable advancing or devicelacement method. Many catheter-based, minimally invasive devices andmethods for performing intravascular procedures, for example, are wellknown, and any such devices and methods, as well as any other devices ormethod later developed, may be used to advance or position deliverydevice 520 in a desired location. For example, in one embodiment asteerable guide catheter is first advanced in retrograde fashion throughan aorta, typically via access from a femoral artery. The steerablecatheter is passed into the left ventricle of the heart and thus intothe space formed by the mitral valve leaflets, the left ventricular walland cordae tendineae of the left ventricle. Once in this space, thesteerable catheter is easily advanced along a portion (or all) of thecircumference of the mitral valve. A sheath is advanced over thesteerable catheter within the space below the valve leaflets, and thesteerable catheter is removed through the sheath. Anchor delivery device520 may then be advanced through the sheath to a desired position withinthe space, and the sheath may be removed. In some cases, au expandablemember coupled to delivery device 520 may be expanded to wedge orotherwise move delivery device 520 into the corner formed by the leftventricular wall and the valve leaflets to enhance its contact with thevalve annulus. Of course, this is but one exemplary method for advancingdelivery device 520 to a position for heating a valve, and any othersuitable method, combination of devices, etc. may be used.

As shown in FIG. 10B, when delivery device 520 is positioned in adesired location for deploying anchors 526, anchor contacting member 530is retracted to contact and apply force to a most-distal anchor 526 tobegin deploying anchor 526 through aperture 528 and into tissue of thevalve annulus VA. FIG. 10C show anchor 526 further deployed out ofaperture 528 and into valve annulus VA. FIG. 10D shows the valve annulusVA transparently so that further deployment of anchors 526 can be seen.As shown, in one embodiment of the invention, anchors 526 include twosharpened tips that move in opposite directions upon release fromhousing 522 and upon contacting the valve annulus VA. Between the twosharpened tips, an anchor 526 may be looped or have any other suitableeyelet or other device for allowing slidable coupling with a tether 534.

Referring now to FIG. 10E, anchors 526 are seen in their fully deployedor nearly fully deployed shape, with each pointed tip (or “arm”) of eachanchor 526 having curved to form a circle or semi-circle. Of course, invarious embodiments anchors 526 may have any other suitable deployed andundeployed shapes, as described more fully above. FIG. 10F shows anchors526 deployed into the valve annulus VA and coupled with tether 534, withthe distal-most anchor 526 coupled attached fixedly to tether 524 atattachment point 536. At this stage, tether 534 may be cinched totighten the annulus, thus reducing valve regurgitation. In someembodiments, valve function may be monitored by means such asechocardiogram and/or fluoroscopy, and tether 534 may be cinched,loosened, and adjusted to achieve a desired amount of tightening asevident via the employed visualization technique(s). When a desiredamount of tightening is achieved, tether 534 is then attached to amost-proximal anchor 526 (or two or more most-proximal anchors 526),using any suitable technique, and tether 534 is then cut proximal to themost-proximal anchor 526, thus leaving the cinched, tethered anchors 526in place along the valve annulus VA. Attachment of tether 534 to themost-proximal anchor(s) 526 may be achieved via adhesive, knotting,crimping, tying or any other technique, and cutting tether 534 may alsobe performed via any technique, such as with a cutting member coupledwith housing 522.

In one embodiment, cinching tether 534, attaching tether 534 tomost-proximal anchor 526, and cutting tether 534 are achieved using atermination device (not shown). The termination device may comprise, forexample, a catheter advancable over tether 534 that includes a cuttingmember and a nitinol knot or other attachment member for attachingtether 534 to most-proximal anchor. The termination catheter may beadvanced over tether 534 to a location at or near the proximal end ofthe tethered anchors 526. It may then be used to apply opposing force tothe most-proximal anchor 526 while tether 534 is cinched. Attachment andcutting members may then be used to attach tether 534 to most-proximalanchor 526 and cut tether 534 just proximal to most-proximal anchor 526.Such a termination device is only one possible way of accomplishing thecinching, attachment and cutting steps, and any other suitable device(s)or technique(s) may be used.

In some embodiments, it may be advantageous to deploy a first number ofanchors 526 along a first portion of a valve annulus VA, cinch the firstanchors to tighten that portion of the annulus, move the delivery device520 to another portion of the annulus, and deploy and cinch a secondnumber of anchors 526 along a second portion of the annulus. Such amethod may be more convenient, in some cases, than extending deliverydevice 520 around all or most of the circumference of the annulus, andmay allow a shorter, more maneuverable housing 522 to be used. In someembodiments, for example, an anterior, portion of a valve annulus mayfirst be tightened, and then a posterior portion may be tightened.

Although the foregoing is a complete and accurate description of thepresent invention, the description provided above is for exemplarypurposes only, and variations may be made to the embodiments describedwithout departing from the scope of the invention. Thus, the abovedescription should not be construed to limit the scope of the inventionas described in the appended claims.

What is claimed is:
 1. A method of constricting a valve annulus in aheart, the method comprising: securing a first implant to a first lengthof a valve annulus; securing a second implant to a second length of thevalve annulus, the second implant comprising a plurality of anchorscoupled to a tether; applying tension to the tether to cinch the anchorstogether to constrict the valve annulus; and securing the tether in itstensioned state.
 2. The method of claim 1, wherein the first length ofthe valve annulus is located on a vertricular side of the valve annulus.3. The method of claim 2, wherein the second length of the valve annulusis also located on a ventricular side of the valve annulus.
 4. Themethod of claim 1, wherein the valve annulus comprises an area of heartwall tissue at a junction of a ventricular wall and an atrial wall. 5.The method of claim 1, wherein the valve annulus is a mitral valveannulus of the heart.
 6. The method of claim 5, wherein the secondlength of the valve annulus is at an intersection of a left ventricularwall and a mitral valve leaflet.
 7. The method of claim 5, wherein thesecond length of the valve annulus is located in a space defined by anintersection of a left ventricular wall and an inferior side of a mitralvalve leaflet.
 8. The method of claim 5, wherein the second length ofthe valve annulus comprises tissue located between a left ventricularwall, at least one mitral valve leaflet and at least one chordaetendineae of the heart.
 9. The method of claim 1, wherein the firstlength of the valve annulus is an anterior length of the valve annulusand the second length of the valve annulus is a posterior length of thevalve annulus.
 10. The method of claim 1, wherein the first implantcomprises a second plurality of anchors coupled to a second tether. 11.The method of claim 1, wherein the first implant comprises astabilization device.
 12. The method of claim 1, wherein the firstimplant comprises a prosthesis.
 13. The method of claim 12, whereinsecuring the first implant to the first length of the valve annuluscomprises securing the prosthesis to the annulus using a secondplurality of anchors coupled to a second tether.
 14. The method of claim1, wherein the first implant comprises an artificial valve.
 15. Themethod of claim 1, wherein the first implant comprises a cuff.
 16. Themethod of claim 1, wherein the first implant comprises a valve repairring.
 17. The method of claim 1, wherein the valve annulus is atricuspid valve annulus of the heart.
 18. The method of claim 1, whereinsecuring the first implant comprises contacting the valve annulus from aleft atrium of the heart with a delivery device.
 19. The method of claim1, wherein the valve annulus is a mitral valve annulus, the secondlength of the valve annulus is located on an inferior side of anintersection of a left ventricular wall and at least one mitral valveleaflet of the heart, and wherein securing the second implant comprisesadvancing an anchor delivery device through an aorta and into a leftventricle of the heart to contact the second length of the valveannulus.
 20. The method of claim 1, wherein securing the first implant,securing the second implant, applying tension to the tether and securingthe tether are performed as part of an open heart surgical procedure.21. The method of claim 1, wherein securing the first implant, securingthe second implant, applying tension to the tether and securing thetether are performed without stopping the heart.
 22. The method of claim1, wherein securing the first implant, securing the second implant,applying tension to the tether and securing the tether are performedthrough one or more minimally invasive incisions.
 23. The method ofclaim 1, wherein securing the tether in its tensioned state comprisessecuring the tether to a terminal anchor of the plurality of anchors,and the method further comprises cutting the tether to leave the cinchedanchors secured to the second length of the valve annulus.
 24. Themethod of claim 23, further comprising advancing a termination devicehaving an attachment member and a cutting member over the tether,attaching the tether to the terminal anchor using the attachment member,and cutting the tether using the cutting member.
 25. The method of claim1, wherein securing the first implant to the first length of the valveannulus comprises securing at least one heart valve prosthesis to thefirst length using a second plurality of anchors coupled to a secondtether.